Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

Cameroon Baptist Convention Health

Status: Unknown

Conditions: Sickle Cell Disease

Treatments: Other: Pediatric Quality of Life - Sickle Cell Disease Module; Drug: Ketamine; Other: Standard Pain Therapy; Other: Faces Pain Scale - Revised; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02573714

TFDA0015/CTR/0015/9 (Other Identifier)

NIMR/HQ/R.8a/Vol. IX/2299 (Other Identifier)

MNH/IRB/I/2015/14 (Other Identifier)

IRB2015-07

Details and patient eligibility

About

The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.

Full description

This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.

Enrollment: 160 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sickle cell disease (SCD)
• Vasoocclusive pain crisis
• Requiring analgesia

Exclusion criteria

• Anatomic variations of nose precluding intranasal medication administration

• Ketamine allergy

• Non-verbal

• Obtunded

• Pregnant

• Other acute SCD complications:

  • Acute chest syndrome
  • Sepsis
  • Stroke
  • Splenic sequestration
  • Pulmonary embolism
  • Acute osteomyelitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups, including a placebo group

Intranasal Ketamine

Experimental group

Description:

Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.

Treatment:

Other: Faces Pain Scale - Revised

Drug: Ketamine

Other: Standard Pain Therapy

Other: Pediatric Quality of Life - Sickle Cell Disease Module

Normal Saline

Placebo Comparator group

Description:

Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.

Treatment:

Other: Faces Pain Scale - Revised

Other: Standard Pain Therapy

Other: Pediatric Quality of Life - Sickle Cell Disease Module

Drug: Normal Saline